Botaneco’s oleosome-based sunscreen meets requirements of FDA monograph

By Katie Nichol

- Last updated on GMT

Related tags Fda sunscreen monograph Sunscreen Fda

Canadian life sciences and technology company Botaneco has announced the compliance of its oleosome-based sunscreen formulation with the FDA sunscreen monograph, which can now be marketed in the US with an SPF 30 claim.

The FDA sunscreen monograph requires that in vivo ​testing be carried out on a 20-person panel before an SPF value can be claimed. The most recent in-vivo ​test carried out by the company, which revealed an SPF value of 30, builds from previous, smaller panel tests.

“Because the larger panel size allows us to meet the requirements of the FDA sunscreen monograph, finished goods manufacturers can now market our oleosome based sunscreen formulation and claim SPF 30 protection,”​ said Botaneco’s vice president of R&D, Jack Guth.

Advantages of using olesome-based formulation

According to Botaneco, using an oleosome-based sunscreen formulation may lead to both cost-saving and safety benefits.

The prototype formulation used in the in-vivo​ trials contained a total of 2.5 percent UV absorbers. In comparison, a non oleosome-based formulation would require in the range of 15 - 20 percent active ingredients, said Guth.

In addition to the potential cost savings, the use of a lower level of active ingredients can be beneficial to the consumer from a safety point of view, according to the company, thus avoiding certain UV-absorbing chemicals that can potentially penetrate the skin, enter the bloodstream, and cause damage to soft tissues.

“Having less active ingredients is beneficial to the consumer as we have to remind ourselves that these ingredients can penetrate the skin,”​ Guth told USA.

Mechanism of action

Guth said that although the mechanism of action of the olesome-based system has not been completely isolated, the formulation could work in several ways.

“For example, the olesome-based formulation is much more uniform when it goes on the skin, meaning that less UV particles get through,” ​said Guth. “Additionally, as the oleosome breaks and releases its contents, it has the opportunity to fill in ‘holes’ on the skin,” ​he added.

According to Botaneco, as well as being used as a sunscreen, the formulation can be used in cosmetic products claiming SPF protection such as moisturizers.

Related topics Formulation & Science

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